CAR BCMA-70 CAR-T Cells for the Treatment of High-risk Plasma Cell Neoplasms (NCT07416682) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
CAR BCMA-70 CAR-T Cells for the Treatment of High-risk Plasma Cell Neoplasms
China20 participantsStarted 2026-01-31
Plain-language summary
This is a single arm study to evaluate the safety and efficacy of CAR BCMA-CD70 CAR-T cell therapy for high-risk plasma cell neoplasms.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subject or their legally acceptable representative has provided written informed consent and is willing and able to comply with all scheduled study visits, study treatment administration, laboratory tests, and other required trial procedures.
. Clinically diagnosed with high-risk plasma cell neoplasm, meeting any one of the following molecular/cytogenetic or clinical criteria:
. Deletion of the short arm of chromosome 17 (del(17p)) with clonal proportion ≥ 20%, and/or TP53 gene mutation;
. IgH translocation (t(4;14), t(14;16), or t(14;20)) combined with 1q amplification (1q+) and/or deletion of the short arm of chromosome 1 (del(1p32));
. Chromosome 1 abnormalities: monoallelic del(1p32) plus 1q+, or biallelic del(1p32);
. β₂-microglobulin ≥ 5.5 mg/L with normal serum creatinine (\< 1.2 mg/dL).
. Age 18 to 75 years (inclusive), male or female.
. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
Exclusion criteria
. Severe cardiac insufficiency with left ventricular ejection fraction (LVEF%) \< 50%.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.
Timeframe: up to 3 years
2
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.
Timeframe: MTD will be determined based on DLTs observed during the first 28 days of study treatment
Trial details
NCT IDNCT07416682
SponsorAffiliated Hospital to Academy of Military Medical Sciences
. History of severe chronic lung disease associated with impaired pulmonary function.
. Concurrent active or progressive malignant tumors other than the target plasma cell neoplasm.
. Concurrent severe infection that cannot be effectively controlled with standard therapy.
. Concurrent severe autoimmune disease or congenital immunodeficiency disorders.
. Active viral hepatitis, defined as hepatitis B virus DNA (HBV-DNA) or hepatitis C virus RNA (HCV-RNA) levels above the lower limit of detection (LLOD).
. Human immunodeficiency virus (HIV) infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection.
. History of severe allergic reactions to biological products, including antibiotics.